Evaluation of the role of unattended sleep monitoring in the management of patients with sleep apnoea being treated with an oral appliance.

Not Applicable

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12609000533291
• Lead Sponsor: Institute for Breathing and Sleep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Mild to moderate obstructive sleep apnoea (OSA) referred for oral appliance treatment

Exclusion Criteria

Poor oral hygiene
Inadequate dentition
Unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Apnoea Hypopnoea Index will be the primary outcome. This outcome will be measured by a full in-laboratory overnight polysomnogram.[For participants in the control arm this endpoint will be measured 1 month after participants are comfortable with using the oral appliance on a nightly basis. For participants in the intervention arm, it will be measured 1 month after advancement is considered to be optimal.]

Secondary Outcome Measures

Name	Time	Method
Quality of Life - measured by Functional Outcomes of sleep questionnaire and the sf36 questionnaire<br>Symptoms - measured by the Sleep Apnoea Symptom Questionnaire<br>Subjective Sleepiness - measured by the Epworth Sleepiness Scale[For participants in the control arm this endpoint will be measured 1 month after participants are comfortable with using the oral appliance on a nightly basis. For participants in the intervention arm, it will be measured 1 month after advancement is considered to be optimal.]